Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.

Bilateral Edentulous Mandible (Kennedy Class I) Clinical Trial

— OTCap  

Official title:

Treatment Outcomes Based on Patient's Oral Health Related Quality of Life (OHRQoL) After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures in Distal Extension Cases: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02924142
• Other study ID #: CEBD-CU-2016-09-212
• Status: Not yet recruiting
• Phase: N/A
• First received: October 3, 2016
• Last updated: October 3, 2016
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Rania M. Hassan, MSC
• Phone: (+02) 010 018 05207
• Email: rtmohamza2004[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

PICOTS:

P: Kennedy class І patients

I : Mandibular removable partial denture with OT Cap attachment

C: Mandibular removable partial denture with gingival approaching clasp assembly

O: 1ry outcome: Oral Health Related Quality of Life

2ry outcome: Biting force

T: 1 Year

S : Randomized control trial

Research question:

In Kennedy class І patients will the removable partial denture with OT Cap attachment compared to conventional removable partial denture with clasp assembly results in difference in Oral Health Related Quality of Life of Patients?

Description:

In bilateral edentulous mandible with missing molars, the clasp retained partial denture will be compared with precision attachment partial denture for better quality of life for patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with mandibular free end saddle cases.

2. Patients less than 75 years old.

3. Patients who approved to be included in the trial and signed the informed consent.

4. Patients are not suffering from diabetes mellitus.

Exclusion Criteria:

1. Patients are suffering from diabetes mellitus.

2. Patients above 75 years old.

3. Patients are receiving chemotherapy or radiotherapy.

4. Patients with severe Temporomandibular Joint problems.

5. Patients who refused the trial.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Edentulous Mandible (Kennedy Class I)
• Mouth, Edentulous

Intervention

Device:
• OT Cap attachment
The RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Health Related Quality of Life	Questionnaire	1 Year	Yes
Secondary	Biting force	i-load Star Sensor	1 Year	Yes